US Stem Cell Inc (USRM)

[cvinvestor]

The California case submitted as an Addendum is harder to read, but has some strong points, with the CA judge clearly siding with USRM's interpretation of the SSP Exeption and against the FDA's interpretation/application which would deny the SVP procedure solely based on the argument that the cells implanted are not the complete tissue that was removed. Judge clearly rejects that argument and states basically that the only point in dispute that could win the case for FDA is whether or not the SVF cells removed are altered before they are implanted again. USRM argues they are not altered and judge basically outlines that if USRM can prove that the SVF cells that they are extracting as part of the adipose (fat) tissue are not altered by the centrifuge/extraction process, then they win the case. At least that is my understanding of the reading.

Based on that case and outline of arguments, things look very good for USRM's outcome. The question is how long will this all take?

Page 13 of 13CIVIL MINUTES—GENERALInitials of Deputy Clerk MG

Finally, this reading [judge's applying of USRM's arguments] of the SSP Exception is entirely consistent with the Government’s assertion that the implanted HCT/P’s be “in the form removed from the patient.” (See Summary Judgment Reply at 4.) It is also consistent with the Guidance Document’s statement that “[a]n HCT/P remains ‘such HCT/P’ when it is in its original form.” Guidance Document at 7. If SVF cells are removed from a patient and those same cells are implanted back into the same patient without alteration of the cells themselves, they are “in the form removed” and “in [their] original form”—even when they were removed along with other biological material that was not ultimately implanted back.